Among the most common health issues affecting women today is that of breast health, most notable of which includes fibrocystic breast disease or related fibrotic conditions, premenstrual or cyclic breast pain and tenderness, breast cancer, elevated or excessive mammographic breast density, and even unexplained breast pain and tenderness without clear association with an identifiable disease or condition.
Fibrocystic breast disease is a benign condition in pre-menopausal women characterized by the presence of lumps and fluid-filled cysts in the breasts that may be associated with cyclic or non-cyclic pain (mastalgia) and tenderness. Fibrocystic breast conditions include atypical palpatory findings such as breast nodularity (diffuse or localized), breast thickening or swelling, tenderness, lumpiness, cysts, discrete masses, fibrosis, and pain, although breast pain may also occur in the absence of palpable lumps or cysts. A physical exam, mammography or ultrasound, biopsy of the breast, or a fine needle aspiration of larger cysts are used principally as diagnostic strategies to rule out the possibility of breast cancer or underlying malignancy.
The occurrence of fibrocystic breast disease is widespread. It is believed that almost 50% of women of child-bearing age in the United States are afflicted by and suffer from the symptoms of fibrocystic breast disease, which most commonly includes at least some degree of mastalgia or breast pain in many of these women.
Mastalgia associated with fibrocystic breast disease is often characterized as moderate to severe pain that lasts for more than about four days per month. The pain and tenderness may be either cyclic or non-cyclic, with cyclic mastalgia occurring regularly during the luteal phase of the menstrual cycle. Cyclic mastalgia associated with fibrocystic breast disease, however, is distinguishable from the cyclic pain and tenderness associated with breast swelling as a normal aspect of the premenstrual cycle, in that cyclic mastalgia associated with fibrocystic breast disease is typically more severe and lasts longer, usually from about 5 to 14 days.
It is believed that mastalgia associated with fibrocystic breast disease is caused by or somehow related to factors such as ovarian hormone changes, intake of caffeine and caffeine-containing products, excessive dietary intake of saturated fat, low intake of dietary fiber, stress, and other factors. Hormonal dysfunction, for example, may involve a progesterone deficiency in the luteal phase of the menstrual cycle, excess production of estrogen or prolactin, or a heightened sensitivity of breast tissue to the action of normal levels of circulating estrogen or prolactin. Estrogen has been found to increase fluid and sodium retention that may lead to swelling and generalized fibrocystic changes in the breasts. The role of estrogen and prolactin as central mediators of the pain and changes in breast physiology associated with fibrocystic breast disease is evidenced by the efficacy of drugs such as danazol and bromocriptine that interfere with these hormonal activities.
Current treatments for mastalgia associated with fibrocystic breast disease include dietary modifications or supplements, steroidal and non-steroidal anti-inflammatory drugs or analgesics, changes in hormone therapy (e.g., oral contraceptives), or other prescription medications. Non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen, ketoprofen, and others, are commonly used in this context but often provide inadequate pain relief in many women. Hormone-based medications such as danazol (estrogen antagonist), bromocriptine (prolactin inhibitor), tamoxifen or raloxifene (partial estrogen antagonist) are also prescribed for women afflicted with fibrocystic breast disease but moderate to severe side effects limits its use in many women, especially when these hormone-based medications are continued over long periods of time.
Still other known or suggested treatments for treating fibrocystic breast disease include the use of various nutrients or supplements, some of which include vitamin E, evening primrose oil or borage oil with gamma linolenic acid (GLA), vitamin B6, thiamine, iodine, and vitamin A.
Many of these treatments, however, have been met with only limited success. Iodine, for example, is often limited by its potential for dose-related toxicity, especially at those doses believed to be most therapeutic for treating fibrocystic breast disease symptoms. Due in part to toxicity concerns, iodine is less often used in fibrocystic breast disease than other nutrients such as GLA, a polyunsaturated fatty acid that has likewise shown promise in treating fibrocystic breast disease symptoms. GLA has been found to be effective in treating fibrocystic breast disease while causing few if any serious side effects. Although GLA has been shown to be somewhat effective in treating fibrocystic breast disease, it is often limited in use by its eggy, chicken fat, sulfidy off-flavor, as well as the large number capsules often needed to provide a therapeutic daily dose.
Moreover, many women suffer from various breast-related health issues other than or in addition to fibrocystic breast disease. These other conditions include premenstrual or cyclic breast pain and tenderness, the development of breast cancer or other estrogen-sensitive cancers, elevated or excessive mammographic breast density with or without associated fibrocystic breast disease, and even unexplained breast pain and tenderness without any clear association of an identifiable disease or condition. Common to all such breast-related issues is that no single treatment method provides complete relief from symptoms in all women without any significant side effects.
There is, however, substantial overlap among the different treatments for fibrocystic breast disease as discussed above and the treatments for other breast related-diseases or conditions. Analgesics, for example, are often prescribed for many of these other breast-related conditions, most notable of which includes the breast pain and tenderness associated with premenstrual cycles. As with treatments for fibrocystic breast disease, there remains for other breast-related diseases or conditions a need for alternative treatments that potentially help more women, provide improved relief from symptoms, and enhance the quality of life in women who have historically suffered for lack of sufficient treatments.
It is therefore an object of the present invention to provide an alternative treatment for women afflicted with fibrocystic breast disease and other breast-related diseases or conditions, and further to provide a treatment that is highly effective in reducing associated breast pain and tenderness, reducing mammographic breast density, reducing the rate or risk of undesirable cell proliferation in breast tissue, or combinations thereof.
It is a further object of the present invention to provide such a treatment that is well tolerated by individuals, and further to provide such a treatment this is potentially even more effective in reducing breast pain and tenderness than currently available treatments. It is further object of the present invention to provide such a treatment through the daily oral administration of a well-tolerated, highly effective, nutritional product.
It is a further object of the present invention to provide a nutritional composition or medical food that can be taken as a single, daily, nutritional product by women afflicted with fibrocystic breast disease or other breast-related diseases or conditions, which combines the therapeutic benefits of iodine, GLA, and optional selenium, in a product form that provides for improved patient compliance, improved oral tolerance, improved relief from breast pain and tenderness, reduction in mammographic breast density, reduction in the rate or risk of undesirable cell proliferation in breast tissue, fewer or less severe side effects, or combinations thereof.
These and other objects of the present invention are described and shall be apparent from the description as set forth hereinafter.